Global Medicines Regulatory Lead

19 hours ago


Harlow, Essex, United Kingdom Teva Pharmaceuticals Full time
Job Overview

Teva Pharmaceuticals is seeking a talented Global Medicines Regulatory Lead to join our Regulatory Affairs team.

As a key member of our team, you will be responsible for developing and implementing regulatory strategies for innovative medicinal products in the EU and globally.

Key Responsibilities

  • You will develop regulatory strategies during development, approval and post approval phases for submissions to EU Competent Authorities.
  • You will obtain regulatory approvals and other feedback or decisions from European Competent Authorities during development of innovative medicinal products.
  • You will support Clinical Trial Applications under the new Clinical Trials Regulation.
  • You will obtain registrations for innovative medicinal products, in the EU and ensure that the registrations for existing marketed products are maintained.

About You

  • You have a strong scientific background with a BSc degree in Life or Pharmaceutical/Healthcare Sciences – ideally with a MSc or PhD.
  • You have substantial European regulatory affairs experience.
  • You have experience in Clinical Trial Applications in the EU.
  • Innovative Medicine experience in Immunology and/or Oncology and/or Gastroenterology and/or Respiratory therapeutic areas is a significant advantage.

Benefits

  • You will enjoy a competitive salary range of £80,000 - £110,000 per annum, depending on your experience.
  • You will also receive 25 days of annual leave, a hybrid approach to home working, pension scheme, car or car allowance, life & critical illness insurance, private health insurance for you and your family, sports and health programme, on-site canteen, recognition programs, virtual learning centre, well-being and D&I focused company.


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